Institute for Virology, University Clinics and Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.
Institute for Virology, University Clinics and Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.
J Clin Virol. 2019 Sep;118:1-5. doi: 10.1016/j.jcv.2019.07.004. Epub 2019 Jul 5.
Dengue IgG testing is being recommended before dengue vaccination. Presently, the diagnostic method of choice is the dengue IgG ELISA.
Determine the test performance and concordance of two commercial dengue IgG ELISA kits.
A diagnostic study to examine the sensitivity, specificity, accuracy and concordance of the Panbio Dengue Indirect IgG ELISA kit and the NovaLisa Dengue IgG ELISA kit. Sera (483) were from dengue-endemic regions in Sudan. Test performance characteristics were determined when tests were performed as indicated in the test kits and when the Panbio calibrator sample was used for both tests.
The sensitivity of the Panbio and the NovaLisa ELISA was 91.1% and 99.0% and the specificity was 79.4% and 50.9%. The Panbio test was slightly more accurate (87.5% compared with 84.0%). Quantitative measurement readings of the tests correlated. The calibrator samples gave different cutoff values. Replacing the NovaLisa cutoff sample with the Panbio calibrator sample raised the accuracy of the NovaLisa assay to 88% and increased the concordance of the tests from 82.8 to 93%.
The study shows that the two dengue IgG ELISAs differed clearly in sensitivity and specificity and gave discordant results for 17.2% of the sera. For the most part the discrepancy depended on the calibrator sample. The findings indicate that an optimized dengue IgG calibrator standard can enhance accuracy and concordance of commercial dengue ELISAs. An optimized standard calibrator would make dengue IgG seroprevalence testing more reliable.
登革热 IgG 检测在登革热疫苗接种前被推荐。目前，首选的诊断方法是登革热 IgG ELISA。
确定两种商业登革热 IgG ELISA 试剂盒的测试性能和一致性。
一项诊断研究，用于检查 Panbio 登革热间接 IgG ELISA 试剂盒和 NovaLisa 登革热 IgG ELISA 试剂盒的敏感性、特异性、准确性和一致性。血清（483）来自苏丹登革热流行地区。当按照试剂盒中的说明进行测试以及当两种测试都使用 Panbio 校准品时，确定了测试性能特征。
Panbio 和 NovaLisa ELISA 的敏感性分别为 91.1%和 99.0%，特异性分别为 79.4%和 50.9%。Panbio 试验的准确性略高（87.5%比 84.0%）。两种试验的定量测量读数相关。校准品样本给出了不同的截止值。用 Panbio 校准品代替 NovaLisa 截止值样本，使 NovaLisa 检测的准确性提高到 88%，并使两种检测的一致性从 82.8%提高到 93%。
该研究表明，两种登革热 IgG ELISA 在敏感性和特异性上存在明显差异，对 17.2%的血清产生了不一致的结果。在大多数情况下，差异取决于校准品样本。研究结果表明，优化的登革热 IgG 校准标准可以提高商业登革热 ELISA 的准确性和一致性。优化的标准校准品将使登革热 IgG 血清流行率检测更可靠。
